To Evaluate the Efficacy and Safety of Fenebrutinib Compared with Teriflunomide in Adult Patients with Relapsing Multiple Sclerosis
- Conditions
- Relapsing multiple sclerosis (RMS)MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 27.0Level: PTClassification code 10080700Term: Relapsing multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2019-004857-10-DE
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 736
• Age 18-55 years
• Expanded Disability Status Scale score (EDSS) of 0.0-5.5 at screening
• A diagnosis of RMS in accordance with the revised 2017 McDonald Criteria
• Neurologically stable for at least 30 days prior to randomization and baseline assessments
• Ability to complete the 9-HPT for each hand in < 240 seconds
• Ability to perform the timed 25-Foot Walk Test in <150 seconds
• For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs, women must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period, for 8 weeks after the final dose of study medication, and until the teriflunomide elimination protocol is completed
• For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm, with a female partner of childbearing potential or pregnant female partner, men must remain abstinent or use a condom during the treatment phase, for 8 weeks after the final dose of study drug, and until completion of the teriflunomide elimination protocol. Men must also refrain from donating sperm during this same period
OLE Inclusion Criteria:
• Completed the Double-Blind Treatment (DBT) phase of the study (remaining on study treatment; no other Disease-Modifying Therapy (DMT) administered) and who, in the opinion of the investigator, may benefit from treatment with fenebrutinib.
• Patients randomized to the teriflunomide treatment arm during the DBT phase must undergo the ATEP prior to the first administration of open-label fenebrutinib
• For female participants of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs, women must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period, the OLE treatment phase and for 28 days after the final dose of open-label fenebrutinib. Women must also refrain from donating eggs during this same period
• For male participants: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm, with a female partner of childbearing potential or pregnant female partner, men must remain abstinent or use a condom during the treatment phase, OLE treatment phase and for 28 days after the final dose of open-label fenebrutinib to avoid exposing the embryo. Men must also refrain from donating sperm during this same period
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 736
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• A diagnosis of PPMS or non-active SPMS
• Disease duration of > 10 years from the onset of symptoms and an EDSS score at screening < 2.0
• Any known or suspected active infection at screening or baseline, or any major episode of infection requiring hospitalization or treatment with IV anti-microbials within 8 weeks prior to and during screening or treatment with oral anti-microbials within 2 weeks prior to and during screening. Onychomycosis is not exclusionary unless it is being treated with systemic therapy
• History of cancer including hematologic malignancy and solid tumors within 10 years of screening.
• Known presence of other neurological disorders that could interfere with the diagnosis of MS or assessments of efficacy or safety during the study, clinically significant cardiovascular, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic or gastrointestinal disease
• Any concomitant disease that may require chronic treatment with systemic corticosteroids, or immunosuppressants during the course of the study
• History of alcohol or other drug abuse within 12 months prior to screening
• Any previous treatment with immunomodulatory or immunosuppressive medication without an appropriate washout period
• Receipt of a live or live-attenuated vaccine within 6 weeks prior to randomization
• Female participants who are pregnant or breastfeeding or intending to become pregnant during the study or 8 weeks (with ATEP) after final dose of study drug
• Male participants intending to father a child during the study or 8 weeks (with ATEP) after final dose of study drug
• Presence of cirrhosis (Child-Pugh Class A, B, or C) or Gilbert's Syndrome
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method